Terlipressin

Source: UK SPC (eMC) section 4.2 for Terlipressin Acetate 0.12 mg/ml solution for injection (https://www.medicines.org.uk/emc/product/101175/smpc). INDICATION: acute variceal bleeding. VERBATIM: 'Initially an i.v. injection of 2 mg Glypressin is given every 4 hours. The treatment should be maintained until bleeding has been controlled for 24 hours, but up to a maximum of 48 hours. After the initial dose, the dose can be adjusted to 1 mg i.v. every 4 hours in patients with body weight < 50 kg or if adverse effects occur.' DURATION: maintain until bleeding has been controlled for 24 hours, to a maximum of 48 hours. DOSE REDUCTION: 1 mg i.v. every 4 hours if body weight < 50 kg or if adverse effects occur. ADMINISTRATION: the injection must be given intravenously to avoid local necrosis at the injection site. MONITORING (section 4.4): regular monitoring of blood pressure, ECG or heart rate, oxygen saturation, serum sodium and potassium, and fluid balance is required. Particular care in cardiovascular or pulmonary disease (terlipressin may induce ischaemia and pulmonary vascular congestion) and in hypertension. Should NOT be used in patients with septic shock with a low cardiac output. Extreme caution in patients with a history of QT prolongation, electrolyte abnormalities, or concomitant QT-prolonging medication. Caution in patients with diabetes mellitus or obesity, who appear more prone to cutaneous ischaemia and necrosis. CHILDREN AND ELDERLY: particular caution - experience is limited and the SPC states there is no data available regarding dosage recommendation in these special patient categories; section 4.2 states there is no relevant use in the paediatric population. DIFFERENT INDICATION, DO NOT TRANSPOSE: US labelling (TERLIVAZ) covers hepatorenal syndrome, not variceal bleeding, at 0.85 mg by slow intravenous bolus every 6 hours with day-4 dose adjustment on serum creatinine.